Trials / Terminated
TerminatedNCT04781647
A Study Evaluating ABI-H0731-containing Regimens in Chinese Participants With Chronic Hepatitis B Virus Infection
A Randomized Phase 2a, Multicenter, Open-label Study Evaluating ABI-H0731-Containing Regimens in Patients With Chronic Hepatitis B
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 54 (actual)
- Sponsor
- Assembly Biosciences · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the safety, antiviral activity, and pharmacokinetics of ABI-H0731 in combination with entecavir (ETV) and with ETV plus pegylated-interferon alpha (Peg-IFNα) in Chinese participants with chronic hepatitis B virus infection (cHBV)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ABI-H0731 | Participants will receive ABI-H0731 300 mg tablets orally once daily |
| DRUG | ETV | Participants will receive ETV 0.5 mg tablets orally once daily |
| BIOLOGICAL | Peg-IFNα | Participants will receive Peg-IFNα with a starting dose of 180 µg solution by subcutaneous injection once weekly |
Timeline
- Start date
- 2021-02-18
- Primary completion
- 2022-12-02
- Completion
- 2022-12-02
- First posted
- 2021-03-04
- Last updated
- 2023-10-06
- Results posted
- 2023-10-06
Locations
9 sites across 1 country: China
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04781647. Inclusion in this directory is not an endorsement.